Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)

Summary

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric population.

Timeline

Start

2021-01-22

Primary completion

2022-10-16

Completion

2022-11-16

Publications

• Blanco C, Chang W, Bhatt AJ, Gerday E, Talati AJ, Dereddy N, Singh R, Ryan E, Senterre T. Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):314-323. doi: 10.1002/jpn3.70072. Epub 2025 May 25.

Drugs

Indications